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DAKLINZA

NDA

DACLATASVIR DIHYDROCHLORIDE | N206843 | BRISTOL-MYERS SQUIBB CO

3 strengths5 unique patents0 unique exclusivities

Patent Timeline

5 unique patents by expiration date

Expiring < 1yr (3)Active (2)Today

2027

2028

2029

2030

2031

Today

Jul. 24, 2029

Jun. 13, 2031

Aug. 11, 2027

Aug. 8, 2027

Aug. 8, 2027

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

65 trials from ClinicalTrials.gov, 48 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study to Evaluate the Safety and PK of Elpida® in Healthy Subjects and Patients With Hepatic Impairment and to Assess the Impact of Food Intake and Drug-Drug Interactions With Other Antiviral Drugs NCT03706898	Phase 1	Completed	Viriom	36	2018-10-01 → 2019-04-10
Study to Determine the Safety and Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) in Patients Who Have Previously Not Received the Standard of Care NCT01359644	Phase 2	Completed	Bristol-Myers Squibb	350	2011-06 → 2013-10
A Drug-drug Interaction Study Between Daclatasvir and Atazanavir/Ritonavir or Atazanavir/Cobicistat NCT02565888	Phase 1	Completed	Radboud University Medical Center	16	2015-11 → 2016-01
The Relationship Between MDSCs and NK Cells Activity of CHC Patient Treated by DAAs NCT03188276	Early Phase 1	Completed	Third Affiliated Hospital, Sun Yat-Sen University	52	2016-02-01 → 2017-05-01
A Phase 3, Comparative Study of Asunaprevir and Daclatasvir Combination Therapy Versus Telaprevir Therapy in Japanese HCV Subjects NCT01718145	Phase 3	Completed	Bristol-Myers Squibb	258	2012-11 → 2014-12
Statins in Chronic Hepatitis C Patients Receiving Sofosbuvir/Daclatasvir Combination NCT03490097	Phase 2/3	Completed	Ain Shams University	100	2017-12-01 → 2018-05-23
Efficacy and Safety of All-Oral Combination of Narlaprevir/Ritonavir and Daclatasvir in Treatment-Naїve Patients With Chronic Hepatitis C Genotype 1b NCT03485846	Phase 2	Completed	R-Pharm	105	2017-11-27 → 2018-11-21
Daclatasvir, Asunaprevir Plus Ribavirin for HCV Genotype 1b Without NS5A RAV NCT03004625	Phase 3	Completed	Kaohsiung Medical University Chung-Ho Memorial Hospital	70	2016-11 → 2018-04
Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With Hepatitis C Infection NCT02992457	Phase 4	Completed	Tanta University	10,000	2015-01 → 2019-12
Phase III Hallmark QUAD: ASV+DCV+Peg+Rib (Nulls/Partials)NCT01573351	Phase 3	Completed	Bristol-Myers Squibb	398	2012-05 → 2013-12

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

API Supply Chain4 active DMFs1 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

HETERO LABS LTDDACLATASVIR DIHYDROCHLORIDE

DMF 309752016

ALIVUS LIFE SCIENCES LTDDACLATASVIR DIHYDROCHLORIDE

DMF 324712018

FUXIN LONG RUI PHARMACEUTICAL CO LTDDACLATASVIR DIHYDROCHLORIDE

DMF 333812018

MSN LIFE SCIENCES PRIVATE LTDDACLATASVIR DIHYDROCHLORIDE

DMF 334962018

CIPLA LTDInactiveDACLATASVIR DIHYDROCHLORIDE

DMF 307372016

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Oct 17, 2019	SUPPL -8	View Letter (PDF)
Nov 13, 2017	SUPPL -7	View Letter (PDF)
Feb 15, 2017	SUPPL -6	View Letter (PDF)
Feb 9, 2016	SUPPL -2	View Letter (PDF)
Feb 9, 2016	SUPPL -1	View Letter (PDF)
Feb 9, 2016	SUPPL -3	View Letter (PDF)
Jul 28, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 30MG BASE

RLD

5 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 24, 2015

Patents (5) · 7 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8329159	Jul 24, 2029	—	Yes	—	—	—
8629171	Jun 13, 2031	—	Yes	Yes		—
8642025	Aug 11, 2027	—	Yes	Yes		—
8900566	Aug 8, 2027	—	—	—		—
9421192	Aug 8, 2027	—	Yes	—		—

#002 — EQ 60MG BASE

RLD

5 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 24, 2015

#003 — EQ 90MG BASE

RLD

1 patent0 exclusivities▾

TABLET;ORAL | Approved: Apr 13, 2016